Fabian, C. J., Molina, R., Slavik, M., Dahlberg, S., Giri, S., & Stephens, R. (1990). Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion. Investigational New Drugs, 8, 57–63.

Evaluate effectiveness of pyridoxine for treating PPE in patients with metastatic colon cancer who are receiving continuous 5-FU

Patients were treated with 5-FU 200 mg/m² by continuous infusion (CI) until moderate to severe toxicity developed.

Five previously untreated patients who developed PPE were given oral pyridoxine (50 or 150 mg every day) when moderate PPE changes were noted.

Study conducted between September 1984 and July 1986.

N: 25

KEY DISEASE CHARACTERISTICS: Patients with metastatic colon cancer receiving continuous 5-FU infusion (200–300 mg/m²/day).

SITE: Multi-site

LOCATION: University of Kansas Medical Center; Fred Hutchinson Cancer Research Center

• Non-randomized, non–double-blinded, uncontrolled study

Skin toxicity was graded as follows.

• 0 = Normal
• 1 = Numbness, nail changes, painless swelling, or erythema
• 2 = Painful erythema with or without swelling
• 3 = Moist desquamation

PPE developed in 16 of the 25 patients. The five previously untreated patients who developed PPE received 50 or 150 mg of oral pyridoxine per day when moderate PPE changes were noted. Reversal of PPE without interruption of 5-FU was seen in four out of five patients, and these patients continued 5-FU for a median of six months after developing PPE.

Oral pyridoxine may reduce incidence and severity of PPE symptoms associated with 5-FU continuous infusion.

• Small sample size
• Not randomized and not double-blinded
• Inadequate description of measurement tool/method to grade PPE symptoms